Table 2.
IBSQOL scores [mean (S.E.)] for the alosetron treatment groups and placebo at baseline and Week 12
| Domain | Placebo n = 176* | Alosetron 0.5 mg QD n = 177* | Alosetron 1 mg QD n = 175* | Alosetron 1 mg BID n = 177* |
|---|---|---|---|---|
| Emotional | ||||
| n† | 170 | 170 | 169 | 166 |
| Baseline | 37.5 (1.8) | 34.6 (1.7) | 36.4 (1.9) | 36.4 (1.7) |
| Change from baseline | 16.3 (1.9) | 26.5 (1.9) | 21.4 (1.9) | 23.4 (2.0) |
| Treatment difference | – | 10.1 (2.7) | 5.1 (2.7) | 7.1 (2.8) |
| P-value‡ | – | 0.001 | 0.066 | 0.021 |
| Mental health | ||||
| n† | 170 | 171 | 169 | 166 |
| Baseline | 57.8 (1.8) | 58.3 (1.8) | 58.9 (2.0) | 58.7 (1.9) |
| Change from baseline | 10.2 (1.6) | 19.7 (1.6) | 14.9 (1.6) | 17.3 (1.6) |
| Treatment difference | – | 9.5 (2.2) | 4.7 (2.2) | 7.0 (2.2) |
| P-value‡ | – | <0.001 | 0.036 | 0.003 |
| Sleep | ||||
| n† | 176 | 177 | 174 | 171 |
| Baseline | 59.3 (1.8) | 57.5 (1.8) | 58.6 (1.8) | 59.1 (1.8) |
| Change from baseline | 13.4 (1.5) | 18.4 (1.5) | 16.6 (1.5) | 18.7 (1.5) |
| Treatment difference | – | 5.0 (2.1) | 3.2 (2.1) | 5.3 (2.2) |
| P-value‡ | – | 0.038 | 0.141 | 0.029 |
| Energy | ||||
| n† | 176 | 177 | 174 | 171 |
| Baseline | 40.8 (2.08) | 37.5 (2.0) | 38.6 (2.0) | 38.7 (1.8) |
| Change from baseline | 17.4 (2.0) | 31.6 (2.0) | 25.8 (2.0) | 28.1 (2.1) |
| Treatment difference | – | 14.2 (2.9) | 8.4 (2.9) | 10.7 (2.9) |
| P-value‡ | – | <0.001 | 0.004 | <0.001 |
| Physical functioning | ||||
| n† | 175 | 171 | 170 | 165 |
| Baseline | 56.3 (1.8) | 55.9 (1.8) | 57.6 (2.1) | 55.5 (2.0) |
| Change from baseline | 15.7 (1.6) | 21.9 (1.7) | 19.6 (1.7) | 20.1 (1.7) |
| Treatment difference | – | 6.2 (2.3) | 3.9 (2.3) | 4.4 (2.4) |
| P-value‡ | – | 0.024 | 0.094 | 0.094 |
| Food/diet | ||||
| n† | 176 | 177 | 174 | 170 |
| Baseline | 48.7 (1.7) | 44.9 (1.7) | 46.0 (1.9) | 46.9 (1.7) |
| Change from baseline | 13.7 (1.7) | 22.8 (1.7) | 19.1 (1.7) | 19.8 (1.7) |
| Treatment difference | – | 9.1 (2.4) | 5.4 (2.4) | 6.1 (2.4) |
| P-value‡ | – | <0.001 | 0.023 | 0.02 |
| Social functioning | ||||
| n† | 175 | 177 | 174 | 171 |
| Baseline | 32.0 (1.7) | 31.5 (1.7) | 32.1 (1.8) | 32.3 (1.8) |
| Change from baseline | 16.9 (1.9) | 27.0 (1.9) | 22.9 (2.0) | 26.5 (2.0) |
| Treatment difference | – | 10.0 (2.7) | 6.0 (2.8) | 9.6 (2.8) |
| P-value‡ | – | 0.001 | 0.031 | 0.001 |
| Physical role | ||||
| n† | 175 | 177 | 173 | 171 |
| Baseline | 29.4 (1.8) | 32.0 (1.8) | 31.3 (1.8) | 30.2 (1.8) |
| Change from baseline | 17.3 (2.1) | 28.5 (2.1) | 23.5 (2.1) | 24.7 (2.1) |
| Treatment difference | – | 11.2 (2.9) | 6.2 (3.0) | 7.5 (3.0) |
| P-value‡ | – | <0.001 | 0.036 | 0.024 |
| Sexual relations | ||||
| n† | 89 | 104 | 97 | 103 |
| Baseline | 53.9 (2.8) | 51.8 (2.4) | 52.7 (2.6) | 55.9 (2.5) |
| Change from baseline | 11.4 (2.4) | 16.6 (2.2) | 18.0 (2.3) | 18.7 (2.2) |
| Treatment difference | – | 5.3 (3.2) | 6.7 (3.3) | 7.3 (3.2) |
| P-value‡ | – | 0.103 | 0.084 | 0.063 |
BID, twice daily; ITT, intent-to-treat; LOCF, last observation carried forward; QD, once daily.
*
ITT population (n = 705); scores presented for baseline, change from baseline, and treatment difference are mean (S.E.).
†
LOCF imputed from the ITT population.
‡
Change from baseline to Week 12 in transformed scale-specific scores were analysed using analysis of covariance with effects for treatment and baseline transformed scale score as the covariate. P-values were adjusted for multiple comparisons using the general multiple Simes procedure described by Hommel.